The deviation is a departure from the approved instructions /established standards. There are two types of deviation and given below:

Controlled/ Planned Deviation

Any deviation from documented procedure opted deliberately for a temporary period to manage the unavoidable situation or improving the performance of the operations, without affecting the quality & yield of drug substance and safety of the operations shall be termed as the controlled/ planned deviation.

Uncontrolled/ Unplanned Deviation:

Any deviation occurred in an unplanned or uncontrolled manner such as system failure or equipment breakdown or manual error shall be termed as an uncontrolled/ unplanned deviation.